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NCT05762198
A Randomized Controlled Trial Comparing Water Vapour Thermal Therapy (Rezūm) and TURP
Conditions: Prostate Cancer
Sex: Male
Ages: 50 Years – 80 Years
Phase: NA
Enrollment: 108
Sponsor: Chinese University of Hong Kong
Location: Hong Kong
Summary
This is a randomized controlled trial using a non-inferiority design with the subjects randomized 1:1 to either water vapour thermal treatment (REZUM) arm or transurethral resection of prostate (TURP) arm.
Eligibility Criteria
Inclusion Criteria:Men 50-80 yearsRefractory urinary retention related to benign prostatic hyperplasia (BPH)On urethral Foley's catheter before treatmentProstate size 30-80ml on ultrasoundExclusion Criteria:Prior prostate operationPast or current history of prostate cancerStrong suspicion of prostate cancer (e.g.
Elevated PSA before urinary retention or abnormal prostate on DRE without workup for prostate cancer)Known Urethral stricture / Bladder stone / Hypocontractile bladderKnown neurological diseases which may affect bladder function (e.g.
Parkinsonism, stroke)Contraindicated to undergo TURP or REZUM (e.g.
not fit for GA/SA, active urinary tract infection, fail to be placed in lithotomy position, uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped)
Source: ClinicalTrials.gov (NCT05762198). StuddyBuddy aggregates publicly available trial information.